Insulin lispro Sanofi (insulin lispro)
- Region
- 🇪🇺 EU
- Active substance
- insulin lispro
- Company
- Sanofi Winthrop Industrie
- Status
- Authorised
- Therapeutic area
- Diabetes Mellitus
- CHMP opinion
- Wed 17 May 2017
- EU approval
- Wed 19 Jul 2017
- Designations
- Biosimilar
- Application
- EMEA/H/C/004303
- ATC
- A10AB04
- Official record
- www.ema.europa.eu
Indication
For the treatment of adults and children with diabetes mellitus who require insulin for the maintenance of normal glucose homeostasis. Insulin lispro Sanofi is also indicated for the initial stabilisation of diabetes mellitus.
Regulatory milestones
Insulin lispro Sanofi: shortage ongoing
Solution for injection in a cartridge, Solution for injection in pre-filled pen; Expected resolution: The expected duration of the shortage is unknown.; Alternatives available: Yes · source
Same substance in other markets
- 🇪🇺 Bysumlog Authorised · Sandoz GmbH
- 🇪🇺 Lyumjev (previously Liumjev) Authorised · Eli Lilly Nederland B.V.
- 🇪🇺 Humalog Authorised · Eli Lilly Nederland B.V.
- 🇪🇺 Liprolog Authorised · Eli Lilly Nederland B.V.
- 🇪🇺 Liprolog Withdrawn · Eli Lilly and Company Limited
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.